D-004 in patients with Bening Prostatic Hyperplasia

Comparative study of medium-term effects of D-004 and Saw palmetto (320 mg / d) in patients with benign prostatic hyperplasia (BPH)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000138

Enrollment

100

Registered

2013-01-04

Start date

2013-09-02

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Interventions

Study group (D-004 (code research)): 1 softgel capsules (320 mg) daily, by oral route for 6 months. Control group (Saw palmetto): 1 softgel capsules (320 mg) daily, by oral route for 6 months

Eligibility

Sex/Gender

Male

Age

50 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with 50 years old or older 2. Informed consent 3. IPSS score between 7 and 19 4. Enlarged prostate checked by rectal examination

Exclusion criteria

Exclusion criteria: 1. Prostate Cancer 2. Prior urological surgery 3. Urinary retention 4. Urinary tract infection 5. Criteria to be catheterized in next 3 months 6. PSA> 5 ng / mL 7. Acute myocardial infarction, stroke, transient ischemic attack or major surgery within 6 months previous 8. History of heart failure 9. History of hepatic failure 10. Blood Pressure > 180/110 mm Hg 11. Diagnosed neoplasias 12. Treatment with alpha 1 adrenergic antagonists, inhibitors of 5-alpha reductase, androgens,antiandrogens, cholinergics, anticholinergics,steroids and/or phytotherapy for BPH in 6 months prior study 13. Alcoholism 14. Other problems that limit its response to IPSS 15. Common history of drug allergy or any other condition that affects patient´s health and life during the study

Design outcomes

Primary

Measure	Time frame
International Prostate Symptom Score (Mild 1-7, Moderate 8-18, Severe 19-35). Measuring time: at baseline, and at 2, 4 and 6 months.	—

Secondary

Measure	Time frame
Prostate size (in cm, determined by transrectal ultrasound). Measuring time: at baseline, 6 months after treatment Retention volume (in mm, determined by transrectal ultrasound). Measuring time: at baseline, 6 months after treatment Symptoms relief (subjective assessment of symptoms: no changes, better, worse) Measuring time: 6 months after treatment. Physical exam (Weigth (kg), Blood presure (mm Hg), Cardiac frequency (Pulse por minute)). Measuring time: at baseline, and 2,4 and 6 months. Hematologic parameters (hemoglobin (g / dL), hematocrit (%), leukocyte count (cells x 10 9 / L), red blood cells (cells x 10 12 / L), platelets (cells x 10 9 / L)). Measuring time: at baseline and 6 months. Blood biochemical parameters (alanine amino transferase (ALT) (U / L), aspartate aminotransferase (AST) (U / L), glucose (mmol / L), creatinine (mmol / L), total cholesterol (mmol / L) , Triglycerides (mmol / L), LDL-C (mmol / L), HDL-C (mmol / L)). Measuring time: at baseline and 6 months. PSA test (PSA, ng/mL). Measuring time: at baseline and 6 months. Adverse Events (AE). Measuring time: 2, 4 y 6 months of treatment Description of the AE (name of the event) Intensity of AE(Mild, Moderate, Severe) Relationship (WHO scale- Very probable, Probable, Possible, Remote, Not related, Unknown).	—

Measure

Time frame

Prostate size (in cm, determined by transrectal ultrasound). Measuring time: at baseline, 6 months after treatment Retention volume (in mm, determined by transrectal ultrasound). Measuring time: at baseline, 6 months after treatment Symptoms relief (subjective assessment of symptoms: no changes, better, worse) Measuring time: 6 months after treatment. Physical exam (Weigth (kg), Blood presure (mm Hg), Cardiac frequency (Pulse por minute)). Measuring time: at baseline, and 2,4 and 6 months. Hematologic parameters (hemoglobin (g / dL), hematocrit (%), leukocyte count (cells x 10 9 / L), red blood cells (cells x 10 12 / L), platelets (cells x 10 9 / L)). Measuring time: at baseline and 6 months. Blood biochemical parameters (alanine amino transferase (ALT) (U / L), aspartate aminotransferase (AST) (U / L), glucose (mmol / L), creatinine (mmol / L), total cholesterol (mmol / L) , Triglycerides (mmol / L), LDL-C (mmol / L), HDL-C (mmol / L)). Measuring time: at baseline and 6 months. PSA test (PSA, ng/mL). Measuring time: at baseline and 6 months. Adverse Events (AE). Measuring time: 2, 4 y 6 months of treatment Description of the AE (name of the event) Intensity of AE(Mild, Moderate, Severe) Relationship (WHO scale- Very probable, Probable, Possible, Remote, Not related, Unknown).

—

Countries

Cuba

Contacts

Public ContactSarahi Mendoza Castanno

Natural Products Center

sarahi.mendoza@cnic.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026